Zydus Cadila on Friday announced that it has received restricted emergency use approval from the Indian drug regulator, Drug Controller General of India (DCGI), for the usage of ‘Virafin’, Pegylated Interferon alpha-2b (PegIFN) in treating moderate coronavirus infection in adults.
The approval follows promising results from a late-stage study of the drug, and comes in the course of a massive wave of COVID-19 cases in India, which has overwhelmed its health system and left many hospitals short of critical oxygen supplies.
“A unmarried dose subcutaneous regimen of the antiviral Virafin will make the remedy more convenient for the patients. When administered early on all over Covid, Virafin will help patients recuperate faster and keep away from much of the complications. Virafin will be to be had on the prescription of medical specialist to be used in hospital/institutional setup,” the company said in a filing.
Cadila Healthcare’s inventory rose sharply upon getting the emergency use nod. On Friday, the inventory ended trading 3.4% higher on NSE.
Pegylated Interferon alpha-2b used to be originally approved for liver disease Hepatitis C and launched in India 10 years ago. It is being repurposed to treat Covid-19.
In the multicentric trial conducted in 20-25 centers across India, Zydus said Virafin had shown lesser need for supplemental oxygen, “clearly indicating that it used to be in a position to keep watch over respiratory misery and failure which has been one of the vital major challenges in treating Covid-19.”
Zydus said the drug has also shown efficacy against other viral infections.
Speaking on the development, Sharvil Patel, Managing Director of Cadila Healthcare said, “The truth that we are in a position to offer a therapy which significantly reduces viral load when provided early on can help in better disease management. It comes at a much-needed time for patients and we will be able to continue to supply them access to critical therapies in this battle against Covid-19.”
In its Phase-3 clinical trials, the therapy had shown better clinical improvement in the patients suffering from Covid-19.
“All through the trials, a higher proportion of patients administered with PegIFN arm were RT PCR negative by day 7. The drug ensures faster viral clearance and has several add-on advantages in comparison to other anti-viral agents,” the company said.
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